PMA Clinical Information

In August 2000, the Company received FDA review and acceptance for its 5-step (module) pre-market approval (PMA) submission plan. The first data module of the plan was submitted and accepted shortly thereafter. Modules 2 and 3 were submitted in Q2 and Q3 and accepted by the FDA in Q4 2001. Module Four was submitted and accepted in 2002. The Company is taking action to complete the final module as quickly as possible so that final submission to the FDA can be made, with the expectation of obtaining FDA approval. Marketing efforts in the United States will begin soon thereafter.

 


Developmental Study and PMA Investigational Locations


Cancer Institute of New Jersey, New Brunswick, NJ

Columbia Presbyterian Medical Center, New York, NY

Comprehensive Breast Center of Coral Springs, Coral Springs, FL

Massachusetts General Hospital, Boston, MA

European Institute of Oncology, Milan, Italy

Gustave Roussy Institute, Paris, France

Hospital San Carlos, Madrid, Spain

 


Investigational Device: Limited by Federal Law to Investigational Use Only. Copyright ©2000-2001 DOBI Medical Systems All Rights Reserved.
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